Label: OVERTIME- methyl salicylate, menthol and capsaicin lotion
- NDC Code(s): 27495-008-02, 27495-008-04
- Packager: Physicians Science & Nature Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- USES:
- KEEP OUT OF REACH OF CHILDREN AND PETS.
- WARNINGS:
-
DIRECTIONS:
Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If placed into eyes, rinse with cold water and call a doctor.
- DO NOT USE:
- STOP USE AND ASK A PHYSICIAN:
-
INACTIVE INGREDIENTS:
water, glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Propylene Glycol, Cetyl Alcohol, Dimethyl Isosorbide, Poloxamer 407, Aloe Barbadensis Gel, Borage Oil, Copolymer, Zingiber Officinale Root Extract, Boswellia Serrata Extract, Soy Lecithin, Methylparaben, Propylparaben, DMDM Hydantoin, Sodium Stearoyl Glutamate, Triethanolamine.
- SPL UNCLASSIFIED SECTION
- PHYSICIAN'S SCIENCE AND NATURE, INC.
-
INGREDIENTS AND APPEARANCE
OVERTIME
methyl salicylate, menthol and capsaicin lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27495-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 18 g in 60 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 6 g in 60 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0225 g in 60 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) POLOXAMER 407 (UNII: TUF2IVW3M2) ALOE VERA LEAF (UNII: ZY81Z83H0X) BORAGE SEED OIL (UNII: F8XAG1755S) GINGER (UNII: C5529G5JPQ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DMDM HYDANTOIN (UNII: BYR0546TOW) TROLAMINE (UNII: 9O3K93S3TK) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27495-008-02 50 in 1 CARTON 01/01/2007 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:27495-008-04 50 in 1 CARTON 01/01/2007 2 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2007 Labeler - Physicians Science & Nature Inc. (012485755) Registrant - Westwood Laboratories, LLC (832280635)
